MAUDE Adverse Event Report: MEDTRONIC IRELAND VALIANT CAPTIVIA - FF; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	VAMF3838C200TU
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Ischemia (1942); Occlusion (1984)
Date of Event	05/10/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A valiant stent graft system was implanted in a patient for the endovascular treatment of a 7 cm in diameter thoracic aortic aneurysm.It was reported that the patient presented emergently with dead bowel.The ct revealed that the thoracic aorta was clotted within the valiant stent graft.An open repair was attempted but the patient expired.Per the physician, the cause of the event was related to the patient¿s anatomy and the occlusion/clot may have started at the bend of the valiant stent graft.No additional clinical sequelae were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Film review the cause of the stent graft occlusion leading to the ischemia and patient death could not be determined from the films provided.The anatomy at implant is unknown, films during the implant were not available for review, and the blood flow dynamics could not be assessed from the ct¿s provided.Review of ct¿s from 3 weeks post-implant revealed that 2 valiant stent grafts had been implanted in the patient.The proximal device was positioned just caudal to the lsa and extended across the arch into the descending thoracic.The distal device was positioned overlapping the proximal device ~6cm, and extended into the descending thoracic to ~6cm above the celiac artery.Beginning just past the lsa significant thrombus was seen within the proximal device, and the stent graft was 100% occluded near the base of the arch at the top of the taa, at the overlap junction between the 2 devices.The occlusion extended to the distal end of the devices, and no contrast was seen within the aorta distal to the devices.The proximal device was gradually angulated across the arch ~100° (a-p) from the proximal to the distal end, and the distal device was essentially straight; however, no stent graft kinks were observed.Significant stent graft expansion was observed just past the arch at the start of the taa, near the area where total stent graft occlusion was observed.Within the proximal seal, the stent graft od ranged from 27 ¿ 31mm (23 ¿ 26mm id), and within the taa and overlapping components, the od/id ranged from ~42 ¿ 39mm od (37 ¿ 34mm id).It is unclear if this abrupt expansion in diameter may have caused blood flow disturbances which then contributed to the thrombus and eventual occlusion.The occlusion may also have been caused by a patient condition such as poor distal runoff, an unknown coagulopathy that is now presenting, or a previous history of pad.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA - FF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6608418
• Report Number: 2953200-2017-00903
• Device Sequence Number: 11748
• Product Code: MIH
• UDI-Device Identifier: 00643169346550
• UDI-Public: 00643169346550
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2018
• Device Model Number: VAMF3838C200TU
• Device Catalogue Number: VAMF3838C200TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Initial Date Received by Manufacturer: 05/10/2017
• Supplement Date Received by Manufacturer: 05/10/2017; 09/01/2017
• Initial Report FDA Received Date: 06/02/2017
• Supplement Report FDA Received Date: 09/07/2017; 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 63 YR